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Print | Email | Share | Comments (7)

Most Diabetes Clinical Trials Ignore Everything But Blood Sugar Control

Linda von Wartburg
22 November 2007
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Most diabetes drug trials focus strictly on the medication's effect on blood sugar levels, but ignore that medication's impact on other outcomes that are important to patients, such as quality of life and the risk of complications.

Only one in five trials measures the effect of drugs on quality of life and risk of complications such as death, heart attack, stroke, amputation, blindness, and dialysis. The trials can be smaller, shorter, and cheaper without considering these factors, but they're not necessarily better for patients.

According to a commentary by Victor Montori, MD, of the Mayo Clinic, "the apparent benefits of these trials are a mirage….Patients and society may end up paying dearly for medications that cause more harm than good….The medical community should insist that we invest the resources needed to do trials that ascertain the effect of interventions on patient-important outcomes."

Dr. Montori recommends that instead of focusing strictly on blood sugar control in a mad rush to the marketplace, diabetes drug trials should test the efficacy of medications against outcomes important to patients. Moreover, they should have to prove that they reduce risk of diabetes-related complications, not just lower blood sugar.

Source: Mayo Clinic Press Release, September 2007


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Comments

Posted by Emily on 29 November 2007

It is mostly true that doctors main focus is on blood sugar control and not the overall picture. Many of the prescribed diabetes drugs today and in the past have had horrible side-effects and complcations associated with them. Many people have chosen to treat their diabetes with more natural remedies, namely herbs. Personally, I have taken Eleotin and it has helped me drop more than 300 points in my blood sugars, lose more than 30lbs and regulate my blood pressure so that I don't take prescription drugs anymore..with no harmful side-effects.

We really need to take a long hard look at WHY doctors prescribe these harmful drugs to us. Could it be money??? There's no money in it for them (or the pharmaceutical companies) when people chose more natural remedies.

Posted by TJPJE777 on 29 November 2007

Just a reply to Emily. I also tried the Eleotin product with no real change in my blood sugar levels. I am on metformin and do take some natural products and vitamins as well. One thing that I have found is that metformin did cause my peripheral neuropathy but it seems to have gotten better now that I am taking a vitamin B1 supplement. I have only been typeII for about 8mos now and found the neuropathy only started after the metformin regime. I not sure if anyone can tell me if they have experienced the same thing. I have been told that it was not a side effect of this drug. My father is also on metformin and has experienced the same complications. Is their an effective alternative to metformin?
Terry

Posted by ricklude on 29 November 2007

I had always thought that, testing any kind of drug also included seeking out harmful side effects and other medical problems that would or could be brought about by their use.

Well, well, well! An eye opener of an article!

Good job folks!

Emily. Not all people react the same to any type or kind of treatment(s). I myself am experimenting with cinimmon intake at the moment.

Terry. Perhaps you both can try a combination of other oral meds. Ask your Endo or PMD.

Posted by Ladybird on 1 December 2007

TJP: I would recommend reading about alpha lipoic acid for neuropathy. I had a foot drop and has have mentioned elsewhere here I firmly believe that lipoic acid has cured it completely. The doctors that I have met have told me that they've in their practices met very few people with foot drops, otherwise, completely cured. In Germany it's a prescribed med for neuropathy. Good luck!

Posted by Anonymous on 7 December 2007

How about a "Diabetic Glossary" defining and explaining the words and terms used. For instance wah is a "foot drop"

Posted by draulakh on 13 December 2007

Dr.Aulakh
M.B.B.S
Post graduate dip in preventive and promotive health care
certified course in management of diabetes from india
I've gone through all the comments and i would like to argue on one point that doctors only motive is 2 control bloos sugar,they r writing drugs for money only.Thatz very much wrong.See u people r talking about metformin and itz bad affects.well,I totally disagree with that.Actually metformin should b the first line treatment for type2 obese as well as non obese patients,not becoz of it decreases the gluconeogeneses{formarion of glucose from fats and proteins},not becoz of it decreases the absobtion of carbohydrates,not becoz of it decreases the weight,BUT becoz it increases the senstivity to insulin .The main problem with other OHA'S esp sulfonyl urea is that they continuously hammer the b cells to secrete more insulin and ultimately they get exhausted .METFORMIN preserves the B CELLS.itz mentioned by a gentleman when he started using metformin ,he got neuropathy and same thing happened with his father.ITZ TRUE with METFORMIN there is decrease in vit b complex absorbtion so we routinely add vit b complex esp vit B12 .Only this factor is not enough to lebel it as culprit agent ,In my sense itz a wonderful drug.see ur topic is doctors only concern is 2 control blood sugar,they don't think about the adverse effects of drugs.itz ok well the other side of coin is all the complications of diabetes r due to hyperdlycemia,or glycation of proteins and now tell me how we can ignore this .all the side effects of OHA'S then remain secondary for us.ofcourse i never ignore the sideeffects.sometimes we have to change the medicine due 2 all these things.but be thankful 2 all these drugs THANX

Posted by Anonymous on 21 December 2007

As a human research subject in both the DCCT and the EDIC studies, I have two comments regarding this article. First, both the studies I've been involved in have placed significant importance on patient safety. The DCCT Clinical Trial was especially concerned about the safety of the participants. Second, controlled levels of blood sugar clearly impacts the quality of all aspects of the life of the diabetic. Has this writer not read the results of the DCCT that provide solid evidence that blood sugar control is directly related to the onset of complications?

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